The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0361-2014·Announced 2013-11-27

Aesculap Arcadius XP L Trial Insertion Instrument Recall for Weak Weld

Aesculap is recalling 30 Arcadius XP L Trial Insertion Instruments because a weak weld may cause the device to disassemble during use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect that may cause disassembly during use, presenting a risk of harm where injury has not yet been reported.

Plain-English summary

Aesculap, Inc. is recalling 30 units of the Arcadius XP L Trial Insertion Instrument (model no. ME020R/ME020R-US). The recall is due to a potentially weak weld on the trial inserter shaft block area located near the thumb wheel, which may cause the instrument to disassemble during use.

The affected units were distributed nationwide in the United States to Georgia, Tennessee, California, Wyoming, Nevada, Texas, Oklahoma, Ohio, and Illinois, as well as internationally to Canada.

Healthcare professionals should stop using the affected instruments and contact Aesculap, Inc. for instructions on return or replacement.

The recalled product

Product
Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
Manufacturer
Aesculap, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
30

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • model no. ME020R

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

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